Spotlight: The Berlin Heart and FDA Approval

McGowan Institute’s long-term vision for mechanical heart devices is to use them as a “bridge to transplant” or as a “bridge to recovery,” the latter making transplantation unnecessary.

At the McGowan Institute, researchers are developing and testing ever more advanced heart assist devices. The Institute’s long-term vision for mechanical heart devices is to use them as a “bridge to transplant” or as a “bridge to recovery,” the latter making transplantation unnecessary.

Artificial heart devices provide circulatory support to patients awaiting donor hearts. Most of today’s FDA-approved devices are too large for young patients though. Today McGowan clinical faculty members provide surgical intervention for infants, children, and young adults with congenital cardiac and vascular diseases, cardiomyopathy, and other problems that require their skills and knowledge of advanced technologies.

The Children’s Hospital’s Heart Center is one of the few pediatric heart centers to use the artificial heart device—the Berlin Heart—an innovative bridge to transplantation developed in Europe and currently waiting for FDA approval. To date, doctors must receive from the FDA “emergency use” permission, which it has on two occasions at Children’s. Shanah Bridgett is one of those young patient success stories.

Most recently in the news, another Berlin Heart success story echoed in South Carolina. Again, the combination of the 7-year frustration surrounding the lack of FDA approval of this artificial heart device and the successful use of the device was spotlighted.